# K181312: GrandioSO x-tra

- Pathway: 510(k) (Traditional)
- Applicant: Voco GmbH
- Decided: Aug 22, 2018 after 97 days
- Product code: EBF (Material, Tooth Shade, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
— Class | and Il posterior restorations — Base in class | and |l cavities — Class V restorations — Locking, splinting of loose teeth — Repairing veneers, enamel defects and temporary C&B-materials — Extended fissure sealing — Restoration of deciduous teeth — Core build-up

Source page: https://510kreport.com/device/K181312
Methodology: https://510kreport.com/methodology